Cartridge And Sensor-Dispensing Instrument

ABSTRACT

A disposable cartridge adapted to be used with a sensor-dispensing instrument comprises a housing, test sensors, a mechanical mechanism and moveable seals. The housing forms at least one opening therethrough. The test sensors are stacked in the housing. The test sensors are adapted to assist in testing at least one analyte. The mechanical mechanism is adapted to urge the test sensors in a first direction. One of the test sensors is positioned for ejection from the cartridge. The moveable seals is adapted to be in a closed position that seals the at least one opening so as to provide a substantially moisture-proof and a substantially air-tight cartridge, and one of the moveable seals is adapted to be in an open position that allows one of the test sensors to be moved therethrough.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to application Ser. No. 60/582,712,filed Jun. 24, 2004, which is incorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention generally relates to a cartridge andsensor-dispensing instrument, and, more particularly, to a cartridgethat multiple sensors that are used in analyzing blood glucose or otheranalytes contained therein.

BACKGROUND OF THE INVENTION

The quantitative determination of analytes in body fluids is of greatimportance in the diagnoses and maintenance of certain physiologicalabnormalities. For example, lactate, cholesterol and bilirubin should bemonitored in certain individuals. In particular, determining glucose inbody fluids is important to diabetic individuals who must frequentlycheck the glucose level in their body fluids to regulate the glucoseintake in their diets. While the remainder of the disclosure herein willbe directed towards determining glucose, it is to be understood that themethods of this invention may be used for determining other analytes onselection of an appropriate enzyme.

The results of such tests can be used to determine what, if any, insulinor other medication needs to be administered. In one type of bloodglucose testing system, sensors are used to test a fluid such as asample of blood.

A sensor contains biosensing or reagent material that will react withblood glucose. The testing end of the sensor is adapted to be placedinto the fluid being tested, for example, blood that has accumulated ona person's finger after the finger has been pricked. The fluid is drawninto a capillary channel that extends in the sensor from the testing endto the reagent material by capillary action so that a sufficient amountof fluid to be tested is drawn into the sensor. The fluid thenchemically reacts with the reagent material in the sensor resulting inan electrical signal indicative of the glucose level in the fluid beingtested is supplied to contact areas located near the rear or contact endof the sensor.

Such a sensor is often sensitive to the effects of ambient humidity. Oneway to reduce or eliminate the effects of ambient humidity is toindividually package each of the sensors with desiccant. Such a methodhas a drawback of requiring the unpacking of a strip before each use.Thus, it would be desirable to have a cartridge that would contain aplurality of test sensors that would not require unpacking each stripbefore using. Also, for the convenience and ease of use, it would alsobe desirable to have a simple mechanism to feed the test sensors one ata time for testing by the user. This provides ease of use to normalusers and is especially important for those users who may have somephysical limitations.

SUMMARY OF THE INVENTION

According to one embodiment, a disposable cartridge is adapted to beused with a sensor-dispensing instrument. The disposable cartridgecomprises housing, a plurality of test sensors, a mechanical mechanism,and a plurality of moveable seals. The housing forms at least oneopening therethrough. The plurality of test sensors is stacked in thehousing. The plurality of test sensors is adapted to assist in testingat least one analyte. The mechanical mechanism is adapted to urge theplurality of test sensors in a first direction. One of the plurality oftest sensors is positioned for ejection from the cartridge. Theplurality of moveable seals is adapted to be in a closed position thatseals the at least one opening so as to provide a substantiallymoisture-proof and a substantially air-tight cartridge. One of theplurality of moveable seals is adapted to be in an open position thatallows one of the plurality of test sensors to be moved therethrough.

According to another embodiment, a disposable cartridge is adapted to beused with a sensor-dispensing instrument. The disposable cartridgecomprises housing, a plurality of test sensors, a mechanical mechanism,and at least one moveable seal. The housing forms at least one openingtherethrough. The plurality of test sensors is stacked in the housing.The plurality of test sensors is adapted to assist in testing at leastone analyte. The mechanical mechanism is adapted to urge the pluralityof test sensors in a first direction. The moveable seal is adapted to bein a closed position that seals the at least one opening so as toprovide a substantially moisture-proof and a substantially air-tightcartridge. The moveable seal is adapted to be in an open position thatallows one of the plurality of test sensors to be moved therethrough.

According to one embodiment, a sensor-dispensing instrument comprises adisposable cartridge, instrument housing, and a pusher assembly. Thedisposable cartridge comprises housing, a plurality of test sensors, amechanical mechanism, and at least one moveable seal. The housing formsat least one opening therethrough. The plurality of test sensors isstacked in the housing. The plurality of test sensors is adapted toassist in testing at least one analyte. The mechanical mechanism isadapted to urge one of the plurality of test sensors in a firstdirection. One of the plurality of test sensors is positioned forejection from the cartridge. The at least one moveable seal is adaptedto be in a closed position that seals the at least one opening so as toprovide a substantially moisture-proof and a substantially air-tightcartridge. The at least one moveable seal is adapted to be in an openposition that allows one of the plurality of test sensors to be movedtherethrough. The housing forms a dispensing outlet and is adapted toreceive the disposable cartridge. The pusher assembly includes a sliderand a thin flat bar coupled to the pusher assembly. The flat bar isadapted to slide from a first position to a second position on movementof the pusher assembly. During the movement of the flat bar from thefirst position to the second position, the flat bar contacts one of theplurality of test sensors and pushes it at least partially through atleast one of the moveable seals.

According to a further embodiment, a disposable cartridge is adapted tobe used with a sensor-dispensing instrument. The disposable cartridgecomprises a housing, a plurality of test sensors, a mechanical mechanismcomprising a torsion spring, and a plurality of moveable seals. Thehousing forms at least one opening therethrough. The plurality of testsensors is stacked in the housing. The plurality of test sensors isadapted to assist in testing at least one analyte. The mechanicalmechanism is adapted to urge the plurality of test sensors in a firstdirection. One of the plurality of test sensors is positioned forejection from the cartridge. The plurality of moveable seals is adaptedto be in a closed position that seals the at least one opening so as toprovide a substantially moisture-proof and a substantially air-tightcartridge. One of the plurality of moveable seals is adapted to be in anopen position that allows one of the plurality of test sensors to bemoved therethrough.

According to yet another embodiment, a disposable cartridge is adaptedto be used with a sensor-dispensing instrument. The disposable cartridgecomprises a housing, a plurality of test sensors, a mechanical mechanismcomprising a torsion spring, and at least one moveable seal. The housingforms at least one opening therethrough. The plurality of test sensorsis stacked in the housing. The plurality of test sensors is adapted toassist in testing at least one analyte. The mechanical mechanism isadapted to urge the plurality of test sensors in a first direction. Themoveable seal is adapted to be in a closed position that seals the atleast one opening so as to provide a substantially moisture-proof and asubstantially air-tight cartridge. The moveable seal is adapted to be inan open position that allows one of the plurality of test sensors to bemoved therethrough.

According to another embodiment, a sensor-dispensing instrumentcomprises a disposable cartridge, instrument housing, and a mechanismfor separating a single sensor from a stack of a plurality of sensors.The disposable cartridge comprises a housing, a plurality of testsensors, a mechanical mechanism comprising a torsion spring, and atleast one moveable seal. The housing forms at least one openingtherethrough. The plurality of test sensors is stacked in the housing.The plurality of test sensors is adapted to assist in testing at leastone analyte. The mechanical mechanism is adapted to urge one of theplurality of test sensors in a first direction. One of the plurality oftest sensors is positioned for ejection from the cartridge. The at leastone moveable seal is adapted to be in a closed position that seals theat least one opening so as to provide a substantially moisture-proof anda substantially air-tight cartridge. The at least one moveable seal isadapted to be in an open position that allows one of the plurality oftest sensors to be moved therethrough. The housing forms a dispensingoutlet and is adapted to receive the disposable cartridge. The mechanismfor separating a single sensor from a stack of a plurality of sensorsinvolves a pusher assembly. The pusher assembly includes a slider and athin flat bar coupled to the pusher assembly. The flat bar is adapted toslide from a first position to a second position on movement of thepusher assembly. During the movement of the flat bar from the firstposition to the second position, the flat bar contacts one of theplurality of test sensors and pushes it at least partially through atleast one of the moveable seals.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a front view of a main-housing portion of a cartridgeaccording to one embodiment of the present invention.

FIG. 1 b is a front view of a lid-housing portion of a cartridgeaccording to one embodiment of the present invention.

FIG. 1 c is a side view of the cartridge of FIGS. 1 a and 1 b.

FIG. 1 d is the front view of the main-housing portion of the cartridgeof FIG. 1 a with a conical spring.

FIG. 1 e is the front view of the main-housing portion of the cartridgeof FIG. 1 a with an inverted conical spring.

FIG. 1 f is the front view of the main-housing portion of a modifiedcartridge of FIG. 1 a with a torsion spring in a closed position.

FIG. 1 g is the front view of the main-housing portion of the modifiedcartridge of FIG. 1 a with a torsion spring in an open position.

FIG. 2 a is a top view of a duckbill seal according to one embodiment.

FIG. 2 b is a cross-sectional view taken generally along line 2 b-2 b ofFIG. 2 a.

FIG. 2 c is the cross-sectional view of FIG. 2 b in an open positionwith a test sensor.

FIG. 2 d is a top view of a duckbill seal according to anotherembodiment.

FIG. 2 e is a perspective view of the seal of FIG. 2 d.

FIG. 2 f is a cross-sectional view taken generally along line 2 f-2 f ofFIG. 2 d.

FIG. 2 g is the cross-sectional view of FIG. 2 f in an open positionwith a test sensor.

FIG. 3 a is a top view of a seal according to a further embodiment.

FIG. 3 b is a top view of a seal according to one embodiment.

FIG. 4 is a front view of a cartridge according to yet anotherembodiment of the present invention.

FIG. 5 is a front view of a cartridge according to a further embodimentof the present invention.

FIG. 6 is a front view of a cartridge according to a further embodimentof the present invention.

FIG. 7 a is a front view of a cartridge according to another embodimentof the present invention.

FIG. 7 b is a side view of the cartridge of FIG. 7 a.

FIG. 8 a is a front view of a cartridge according to a furtherembodiment of the present invention.

FIG. 8 b is a side view of the cartridge of FIG. 8 a.

FIG. 9 is a front view of a sensor-dispensing instrument according toone embodiment of the present invention.

FIG. 10 a is a top view of the sensor-dispensing instrument of FIG. 9with a slider in the first position.

FIG. 10 b is a top view of the sensor-dispensing instrument of FIG. 9with a slider in the second position.

FIG. 10 c is a cross-sectional view taken generally along line 10 c-10 cof FIG. 9.

FIG. 11 is an interior view of the sensor-dispensing instrument of FIG.9 with a flat bar in a first position.

FIG. 12 is an interior view of the sensor-dispensing instrument of FIG.9 with the flat bar of FIG. 11 in a second position.

FIG. 13 is an enlarged view of the flat bar just before contacting oneof the test sensors according to one embodiment.

FIG. 14 depicts a front view of a sensor-dispensing instrument withvarious potential positions of the slider.

FIG. 15 is a cross-sectional view of a slider according to anotherembodiment.

FIG. 16 is a cross-sectional view of a slider according to a furtherembodiment.

While the invention is susceptible to various modifications andalternative forms, specific embodiments are shown by way of example inthe drawings and are described in detail herein. It should beunderstood, however, that the invention is not intended to be limited tothe particular forms disclosed. Rather, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

The present invention is directed to a disposable cartridge thatcontains a plurality of test sensors. The plurality of test sensors isused to determine concentrations of analytes. Analytes that may bemeasured using the present invention include glucose, lipid profiles(e.g., cholesterol, triglycerides, LDL and HDL), microalbumin,hemoglobin A₁C, fructose, lactate, or bilirubin. The present inventionis not limited, however, to these specific analytes and it iscontemplated that other analyte concentrations may be determined. Theanalytes may be in, for example, a whole blood sample, a blood serumsample, a blood plasma sample, or other body fluids like ISF(interstitial fluid) and urine.

Disposable Cartridges

Referring to the drawings, a disposable cartridge 10 in FIGS. 1 a-1 c isshown that is adapted to be used in a sensor-dispensing instrument. Thecartridge 10 is a substantially moisture-proof and air-tight device. Thedisposable cartridge 10 of FIGS. 1 a,c comprises a housing 12, aplurality of test sensors 14, a mechanical mechanism 16, and a pluralityof moveable seals 18. The housing 12 for the disposable cartridge 10 maycontain a first section (main-housing section 11 in FIG. 1 a) and asecond section (lid-housing section 28 in FIG. 1 b) that are joinedtogether.

The cartridge 10 is adapted to be disposable after each of the pluralityof test sensors 14 has been used. After each of the plurality of testsensors 14 has been used, the cartridge 10 may be removed from thesensor-dispensing instrument and replaced with a second identicalcartridge that includes a plurality of unused test sensors.

Referring to FIG. 1 a, the housing 12 forms at least one opening 20therethrough. The opening 20 is sealed at two locations using theplurality of moveable seals 18 a,b. The moveable seals 18 a,b prevent orinhibit air and moisture from entering into the interior of thecartridge 10 that contains the plurality of test sensors 14. The opening20 is sized to allow the plurality of test sensors 14 to movetherethrough one at a time and eventually exit the cartridge 10.Specifically, the plurality of test sensors 14, one at a time, exits thecartridge 10 via an opening end 20 a. As will be discussed below in moredetail, the housing 12 may also form at least one notch 22 to assist inholding the cartridge in position within the sensor-dispensinginstrument.

The housing 12 may be made of a variety of materials, but is typicallymade of polymeric material. Some examples of polymeric materials thatmay be used in forming the housing 12 include polycarbonate, ABS, nylon,polystyrene, polypropylene, or combinations thereof. Other additives maybe added in forming the housing such as, for example, TEFLON® forlubrication or glass to provide strength. It is contemplated that otheradditives may be employed. Polycarbonate is desirable for severalreasons including being a durable material and having an ability toprevent or inhibit air (especially oxygen and moisture) from enteringthe housing 12. Additionally, if the housing is formed from two distinctsections, polycarbonate is capable of sealing to itself. This may bedesirable in a process where the two housing sections are sonicallywelded.

In one example, the housing 12 includes the main-housing section 11 andthe lid-housing section 28. The lid-housing section 11 of FIG. 1 b has aplurality of guide pins 29 for precisely locating the lid-housingsection 28 with respect to the main-housing section 11. The main-housingsection 11 of FIG. 1 a forms a plurality of apertures 27 for receiving arespective one of the guide pins 29 of the lid-housing section 11 beforebeing joined together by, for example, sonic welding. To assist inreducing or eliminating moisture and air from entering the housing, atleast one energy director 30 may be added to the lid-housing section 28(such as shown in FIG. 1 b) that assist in sealing the perimeter of thehousing. Alternatively, the at least one energy director may be added tothe main-housing section. The energy directors 30 melt and form a sealaround the perimeter of the housing 12. Alternatively, it iscontemplated that guide pins may be located on the main-housing sectionand the lid-housing section forms apertures for receiving such guidepins. The energy directors 30 are desirably located to maximize thesealing of the housing 12.

The housing 12 may be formed by processes known to those skilled in theart including injection-molding processes. If injection-moldingprocesses are used, the wall thicknesses are typically designed withinnormal ranges. It is contemplated that other processes may be used suchas a molding process.

As shown in FIGS. 1 a,c, the plurality of test sensors 14 is stacked inthe housing 12. The plurality of test sensors 14 is adapted to assist intesting at least one analyte. As discussed above, one of the analytesthat may be tested is glucose from, for example, a whole blood sample.In one embodiment, the plurality of test sensors would include anappropriately selected enzyme to react with the desired analyte oranalytes to be tested. An enzyme that may be used to react with glucoseis glucose oxidase. It is contemplated that other enzymes may be usedsuch as glucose dehydrogenase. An example of a test sensor 14 isdisclosed in U.S. Pat. No. 6,531,040 assigned to Bayer Corporation. Itis contemplated that other test sensors may be used in the disposablecartridge 10.

The plurality of test sensors 14 may vary in number than shown in FIGS.1 a, 1 c so as to address the needs of different users. Typically, thestacked test sensors contain from about 10 to about 50 or 100 sensorsand, more specifically, contain from about 25 to about 40 sensors.Because of limited shelf- and use-life of the test sensors, it isenvisioned that a user who tests infrequently would likely desire acartridge having less test sensors as opposed to a user who tests morefrequently.

To urge the stacked test sensors 14 upwardly (in the direction of arrowA in FIGS. 1 a,c), the mechanical mechanism 16 is used according to oneembodiment. The mechanical mechanism 16 assists in positioning one ofthe plurality of test sensors for eventual ejection from the cartridge10 via opening end 20 a. The mechanical mechanism is any device that canurge pressure on the stacked test sensors 14 so as to position one ofthe plurality of test sensors for ejection. For example, the mechanicalmechanism 16 depicted in FIGS. 1 a,c is a spring. Various types ofsprings may be used as the mechanical mechanism to urge the stacked testsensors 14 in the direction of arrow A in FIGS. 1 a,c. For example, thespring may be a compression spring or a torsion spring. Springs aredesirable because of their simplicity and ease of use.

Another specific type of compression spring is shown in FIGS. 1 d, 1 e.The cartridge 10 of FIG. 1 d is the same as FIG. 1 a except that themechanical mechanism 15 is a conical spring. The cartridge 10 of FIG. 1e is also the same as FIG. 1 a except that the mechanical mechanism 17is a conical spring. The conical spring 17 of FIG. 1 e is inverted ascompared to the conical spring 15 of FIG. 1 d.

According to an embodiment of the invention shown in FIGS. 1 f, 1 g, amodified cartridge 12 includes a mechanical mechanism 19 that comprisesa torsion spring 19 a and a movable pressure plate 19 b. The movablepressure plate 19 b contacts the stack of test sensors. The torsionspring 19 a includes a fixed end member 19 c that attaches the torsionspring 19 a to the cartridge housing 12. The torsion spring 19 a alsoincludes a movable end member 19 d that is attached to a pivot point onthe pressure plate 19 b. The torsion spring 19 a is located to the sideof the stack of test sensors 14. The torsion spring 19 a exerts pressureon the stack of test sensors 14 and facilitates the upward movement ofthe test sensors in the direction of the arrow A in FIGS. 1 f and 1 g.At the same time, the pressure plate 19 b moves in the same directionand holds the remainder of the sensor stack 14 in place.

Additionally, the mechanical mechanism 16 may be a ratchet pusher. Usingsuch an embodiment, the ratchet pusher automatically ratchets thestacked test sensors upwardly (i.e., the direction of arrow A in FIGS. 1a,c). The ratchet pusher would desirably need to extend the length ofthe interior of the cartridge such that all of test sensors wouldeventually be used. It is contemplated that the ratchet pusher may beused in combination with one or more springs.

To assist in guiding the mechanical mechanism 16 upwardly (in thedirection of arrow A in FIGS. 1 a,c), the housing 12 has been formedwith a plurality of prongs or extensions 24. The optional prongs orextensions 24 assist in guiding the mechanical mechanism 16 in agenerally upwardly direction, thus making movement of the plurality oftest sensors in the direction of arrow A easier.

To assist in protecting the reagent(s) in the test sensors 14, desirablepackaging material and/or desiccant material may be used. The disposablecartridge 10 is typically packaged in material that prevents or inhibitsair from entering into an interior of the housing 12 that contains thetest sensors 14. One type of removable packaging that may be used toenclose the disposable cartridge 10 is aluminum foil. It is contemplatedthat other types of removable packaging may be employed. It iscontemplated that desiccant material may be added in the interior of theremovable packaging to assist in maintaining an appropriate humiditylevel therein. If the reagent in the test sensors is not humiditysensitive, then there is little or no need to include much, if any,desiccant. The removable packaging with or without the desiccantmaterial assists in increasing the shelf-use of the test sensors. Theremovable packaging is to be removed before the cartridge 10 is placedinto the sensor-dispensing instrument.

It is contemplated that the disposable cartridge 10 may be initiallyplaced in a polymeric container such as a bottle or other type ofcontainer. The container may be shaped similarly to the disposablecartridge with a desirable seal to prevent or inhibit air or moisturefrom entering the interior of the container. The container may include alid that is attached to the remainder of the container via a livinghinge. It is contemplated that desiccant may also be added within thecontainer. The container with or without the desiccant material assistsin increasing the shelf-use of the test sensors. The disposablecartridge 10 is removed from the container before being placed into thesensor-dispensing instrument.

Desiccant material 26 is desirably added to the disposable cartridge 10to assist in maintaining an appropriate humidity level within theinterior of the housing 12 that contains the test sensors 14.Specifically, some moisture may enter the interior of the housing 12whenever a sensor is pushed out from the disposable cartridge, but suchmoisture is desirably absorbed by the desiccant so as to protect thereagent in the test sensors from degradation. By maintaining anappropriate humidity level, reagent material in the test sensors isprotected. The amount of desiccant material 26 should be sufficient toobtain the desired shelf-life (the time period before any of theplurality of test sensors are used). More specifically, the shelf-lifetypically refers to the time period before the cartridge 10 is removedfrom the packaging material, if used. The amount of desiccant material26 should also be sufficient to obtain the desired use-life (the timeperiod after first use of one of the plurality of test sensors). Morespecifically, the use-life typically refers to the time period after thecartridge 10 is removed from the packaging material, if used.

Examples of desiccant that may be included within the disposablecontainer, the removable packaging enclosing the disposable container,or the container containing the disposable cartridge includecommercially available desiccants. The desiccant may be in the form ofseveral shapes including balls, tablets, granular, or paper. Forexample, the desiccant may be molecular sieve spheres or thick desiccantpaper. The desiccant may be placed within the interior of the housing 12such as shown with desiccant material 26. The desiccant may be moldedinto an interior surface of the housing 12 of the cartridge so as toabsorb moisture within the same. One non-limiting example of desiccantmaterial may be purchased from Multisorb of Buffalo, N.Y. in the formof, for example, molecular sieve beads.

It is contemplated that desiccant may not be used for test sensors thatare not humidity sensitive. The amount of desiccant used, if any,depends on how humidity sensitive the test sensor is and the duration ofthe desired use-life.

The seals 18 a,b are adapted to move from closed positions (shown inFIG. 1 a) to open positions. In a closed position, the plurality ofseals 18 a,b seals the interior of the housing 12 containing the testsensors 14. In such a closed position, the plurality of seals 18 a,bprovides a substantially moisture-proof and a substantially air-tightcartridge. The plurality of seals 18 a,b is desirably designed toprevent or inhibit moisture from entering via either opening ends 20 a,band effecting the plurality of test sensors 14 for at least theshelf-life and use-life of the plurality of sensors. When the moveableseal 18 a is in an open position, the test sensors 14, one at a time,can be moved through the opening 20 so as to eventually exit via theopening end 20 a.

One type of moveable seal that may be used in the cartridge 10 is aduckbill seal. The moveable seals 18 a,b of FIG. 1 a are duckbill seals.Referring to FIGS. 2 a-2 g, two duckbill seals 18, 40 are shown that maybe used as moveable seals in the cartridge.

Referring to FIGS. 2 a-2 c, the duckbill seal 18 is shown with agenerally pyramidal section 32 located in the middle thereof and acircumferentially-extending circular section 34. The generally pyramidalsection 32 includes a first outwardly-extending portion 32 a and asecond outwardly-extending portion 32 b. The first outwardly-extendingportion 32 a includes a surface 32 c and the second outwardly-extendingportion 32 b includes a surface 32 d. In a closed position (FIGS. 2a,b), a portion 36 of each of the surfaces 32 c,d abuts each other toform a substantially moisture-proof and substantially air-tight seal. Inan open position (FIG. 2 c), the first outwardly-extending portion 32 aand the second outwardly-extending portion 32 b are moved or urged awayfrom each other so as to allow a test sensor 14 to proceed therethrough.

Referring next to FIGS. 2 d-2 g, the duckbill seal 40 is shown with agenerally truncated rectangular section 42 located in the middle thereofand a circumferentially-extending rectangular section 44. The generallyrectangular section 42 includes a first outwardly-extending portion 42 aand a second outwardly-extending portion 42 b. The firstoutwardly-extending portion 42 a includes a surface 42 c and the secondoutwardly-extending portion 42 b includes a surface 42 d. In a closedposition (FIGS. 2 d-f), a portion 46 of each of the surfaces 42 c,dabuts each other to form a substantially moisture-proof andsubstantially air-tight seal. In an open position (FIG. 2 g), the firstoutwardly-extending portion 42 a and the second outwardly-extendingportion 42 b are moved or urged away from each other so as to allow atest sensor 14 to proceed therethrough. It is contemplated that theduckbill seals may be shaped differently than depicted in FIGS. 2 a-2 gwith duckbill seals 18, 40.

The duckbill seals 18, 40 of FIGS. 2 a-2 g may be made of materials suchas polymeric materials. For example, silicon (e.g., medical-gradesilicon), rubber, plastomers, elastomers, or other flexible polymericmaterials may be used in forming the duckbill seals. The duckbill seals18,40 need a certain degree of memory. Memory as that term is usedherein is the ability of a material to return to substantially the sameposition after being moved or stretched.

It is contemplated that other type of moveable seals may be used in thedisposable cartridge. For example, spring seals are shown in FIGS. 3 a,3 b. For cost-efficiency and ease of manufacturer, it is desirable forthe spring seals to be made from extruded polymers. It is contemplated,however, that the spring seals may be formed by a molding process.

Referring to FIG. 3 a, a spring seal 50 includes a spring section 50 aand a sealing surface 50 b. Similarly, a spring seal 52 includes aspring section 52 a and a sealing surface 52 b. The seals 50, 52function together to form a closed position as shown in FIG. 3 a. Morespecifically, the sealing surfaces 50 a, 52 b abut each other. The seals50, 52 may be made of material such as silicon (e.g., medical-gradesilicon), rubber, plastomers, elastomers, or other flexible polymericmaterials. The seals 50, 52 need a certain degree of memory. It iscontemplated that the spring sections of the seals 50, 52 may also bemade of material such as metal.

Another type of spring seal is shown in FIG. 3 b with spring seals 60,62. The spring seal 60 includes two spring sections 60 a and a sealingsurface 60 b. Similarly, a spring seal 62 includes two spring sections62 a and a sealing surface 62 b. The seals 60, 62 function together toform a closed position as shown in FIG. 3 b. More specifically, thesealing surfaces 60 a, 62 b abut each other. The seals 60, 62 may bemade of material such as silicon (e.g., medical-grade silicon), rubber,plastomers, elastomers, or other flexible polymeric materials. The seals60, 62 need a certain degree of memory. It is contemplated that thespring sections of the seals 60, 62 may also be made of material such asmetal.

Referring to FIG. 4, a disposable cartridge 110 comprises a housing 112,a plurality of test sensors 114, a mechanical mechanism 116, and aplurality of moveable seals 118. The housing 112 forms at least oneopening 120 therethrough. The disposable cartridge 110 also includesprongs or extensions 124 and desiccant material 126.

The plurality of moveable seals 118 includes a first polymeric-hollowtube 118 a, a second polymeric-hollow tube 118 b, a thirdpolymeric-hollow tube 118 c, and a fourth polymeric-hollow tube 118 d.The first tube 118 a and second tube 118 b function together to form aclosed position as shown in FIG. 4. The first and second tubes 118 a,bare made of flexible material that deforms when a test sensor isinserted therebetween. The first and second tubes 118 a,b may be made ofmaterial such as silicon (e.g., medical-grade silicon), rubber,plastomers, elastomers, or other flexible polymeric materials. The firstand second tubes 118 a,b need a certain degree of memory. The third andfourth tubes 118 c,d function in a similar manner in that they are madeof flexible material that deforms when a bar of the sensor-dispensinginstrument is extended therebetween, which will be discussed below infurther detail. The third and fourth tubes 118 c,d may be made of thesame materials as the first and second tubes 118 a,b.

The plurality of test sensors 114, mechanical mechanism 116, opening120, prong or extensions 124 and the desiccant 126 function in a similarmanner as described above with respect to test sensors 14, mechanicalmechanism 16, opening 20, prong or extensions 24, and the desiccant 26.

Referring to FIG. 5, a disposable cartridge 160 is shown according toanother embodiment. The disposable cartridge 160 comprises a housing162, a plurality of test sensors 164, a mechanical mechanism 166, and aplurality of moveable seals 168 a,b. The housing 162 forms at least oneopening 170 therethrough. The disposable cartridge 160 also includesprongs or extensions 174 and desiccant material 176.

The moveable seals 168 a,b are pivotable seals, which are shown in aclosed position in FIG. 5. In the closed position, the pivotable seals168 a,b exert an upward force. When a test sensor is pushed through theopening 170, the pivotable seal 168 a pivots downwardly and away fromthe opening as viewed in FIG. 5 to an open position. The test sensor 164is allowed to continue thorough to the opening end 170 a. The pivotableseals 168 a,b may be made of polymeric materials such as silicon (e.g.,medical-grade silicon), rubber, plastomers, elastomers, or otherflexible polymeric materials. The pivotable seals 168 a,b need a certaindegree of memory. The pivotable seal 168 b is adapted to pivot when abar of the sensor-dispensing instrument is extended therebetween, whichwill be discussed below in further detail.

The plurality of test sensors 164, mechanical mechanism 166, opening170, prong or extensions 174 and the desiccant 176 function in a similarmanner as described above with respect to test sensors 14, mechanicalmechanism 16, opening 20, prong or extensions 24, and the desiccant 26.

It is also contemplated that the disposable cartridge may be only sealedwith one moveable seal. One example of such an embodiment is shown inFIG. 6. Referring to FIG. 6, a disposable cartridge 260 is shownaccording to another embodiment. The disposable cartridge 260 comprisesa housing 262, a plurality of test sensors 264, a mechanical mechanism266, and one moveable seal 268. The housing 262 forms at least oneopening 270 therethrough. The disposable cartridge 260 also includesprongs or extensions 274 and desiccant material 276.

The moveable seal 268 is shown in a closed position in FIG. 6 andfunctions in the same manner as described above with respect to moveableseal 18 a. The moveable seal 268 may be made of the same materials asdiscussed above with respect to moveable seal 18 a. The disposablecartridge 260 may include a covering 280. The covering 280 may beremoved from the disposable cartridge 260 before the disposablecartridge 260 is placed into a sensor-dispensing instrument. In thisembodiment, after removal of the covering 280, the cartridge 260 is notsubstantially moisture-proof and substantially air-tight until placed ina sensor-dispensing instrument. As will be discussed below, a flat barwill form a fitted or snug seal in the opening 270 b after being placedin the sensor-dispensing instrument.

Alternatively, the covering 280 may remain with the disposable cartridgeafter the disposable cartridge is placed into a sensor-dispensinginstrument. In this embodiment, the opening end 270 b remains sealedduring placement into the sensor-dispensing instrument. In thisembodiment, a flat bar will puncture or rupture the covering 280 as willbe discussed in more detail below. After being punctured or ruptured, aflat bar will form a fitted or snug seal in the opening 270 b afterbeing placed in the sensor-dispensing instrument. The covering 280 maybe made of materials such as aluminum foil or polymeric material.

The plurality of test sensors 264, mechanical mechanism 266, opening270, prong or extensions 274 and the desiccant 276 function in a similarmanner as described above with respect to test sensors 14, mechanicalmechanism 16, opening 20, prong or extensions 24, and the desiccant 26.

It is contemplated that the disposable container 260 may include adifferent seal than depicted in FIG. 6. For example, other sealsdiscussed above, may be used such as moveable seals 50, 118, 168, and218.

It is also contemplated that other shaped disposable cartridge may beused. For example, referring to FIGS. 7 and 8, a disposable cartridge310 and a disposable cartridge 360 are depicted. Referring initially toFIG. 7 a,b, the disposable cartridge 310 comprises a housing 312, aplurality of test sensors 314, a mechanical mechanism 316, and aplurality of moveable seals 318. The housing 312 forms at least oneopening 320 therethrough in which one of the plurality of test sensors314 eventually exits the cartridge 310 via an opening end 320 a. Thedisposable cartridge 310 and its individual components functionsimilarly as discussed above with respect to the disposable cartridge 10and its individual components.

The disposable cartridges are advantageous in many aspects. Thedisposable cartridges are desirably simple to seal, cost-effective andare easy to manufacture in that the process may be performed using atop-down assembly.

Referring next to FIG. 8, the disposable cartridge 360 is depicted. Thedisposable cartridge 360 comprises a housing 362, a plurality of testsensors 364, a mechanical mechanism 366, and a plurality of moveableseals 368 a,b. The housing 362 forms at least one opening 370therethrough in which one of the plurality of test sensors 364eventually exits the cartridge 360 via an opening end 370 a. Thedisposable cartridge 360 also includes an opening end 370 b, prongs 374and desiccant 376. The disposable cartridge 360 and its individualcomponents function similarly as discussed above with respect to thedisposable cartridge 10 and its individual components.

Sensor-Dispensing Instrument

Referring to FIGS. 9-14, a sensor-dispensing instrument 400 is depictedaccording to one embodiment. The sensor-dispensing instrument is used todetermine concentrations of analytes. Analytes that may be measuredusing the present invention include glucose, lipid profiles (e.g.,cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin A₁C,fructose, lactate, or bilirubin. The present invention is not limited,however, to these specific analytes and it is contemplated that otheranalyte concentrations may be determined. The analytes may be in, forexample, a whole blood sample, a blood serum sample, a blood plasmasample, or other body fluids like ISF (interstitial fluid) and urine.

The sensor-dispensing instrument 400 comprises a disposable cartridge10, a pusher assembly 402, and instrument housing 404. As shown in FIG.10 c, the pusher assembly 402 includes a slider 406 and a thin flat bar408 attached to the slider 406. As shown in FIGS. 11 and 12, theinstrument housing 404 is adapted to receive the disposable cartridge10. It is desirable for the cartridge 10 to be removed from and loadedinto the instrument housing 404 of the sensor-dispensing instrument 400in a simple and easy manner. The instrument housing 404 as shown inFIGS. 11 and 12 loads the disposable cartridge via the bottom. Insteadof being a bottom-loading device, the instrument housing may be aside-loading device.

To assist in holding the cartridge 10 in the instrument housing 404, aholding mechanism 430 may be used. The holding mechanism 430 isspring-loaded and includes an extension 430 a that corresponds to thenotch 22 of the cartridge 10 (see FIG. 1). During the process of loadingthe cartridge 10, the holding mechanism 430 is pulled back to a firstposition (in the direction of arrow D of FIG. 11). After the cartridge10 is positioned in the instrument housing 404, the holding mechanism430 is released and proceeds to a second position (FIGS. 11 and 12) inwhich extension 430 a engages the notch 22.

It is contemplated that other disposable cartridges may be used, such asthose previously described above. Depending on the selected cartridge,the interior of the instrument housing may be redesigned to correspondto the selected disposable cartridge. The instrument housing 404 alsoforms a dispensing outlet 410, which is sized to dispense the testsensors 14 one at a time.

Referring to FIGS. 9 and 10 a, the slider 406 is shown in a firstposition. By continuing to manually move the slider 406 in FIGS. 9 and10 a in the direction of arrow B, the slider 406 is moved to a secondposition (see FIG. 10 b). The slider 406 in FIG. 10 b is located closerto the dispensing outlet 410 than the slider of FIG. 10 a.

The pusher assembly 402 is adapted to move one of the plurality of testsensors 14 from the disposable cartridge 10 and at least partiallythrough the dispensing outlet 410, such as shown in FIG. 10 b. When theslider 406 is in the first position (FIGS. 9 and 10 a), the flat bar 408(which is also in its first position in FIG. 11) does not contact any ofthe plurality of test sensors 14. As the slider 406 is moved in thedirection of arrow B (see FIG. 10 a), the flat bar 408 (see FIG. 11) isalso moved in the direction of arrow B.

Referring to FIG. 13, an enlarged view is shown of the flat bar 408 justbefore contacting one of the stacked test sensors 14. In thisembodiment, the flat bar includes a tapered end 408 a. It is desirableto have a tapered end 408 a of the flat bar 408 to assist in pushing oneof the test sensors from the cartridge, while at the same timepreventing the next one of the stacked test sensors from being removedat the same time. It is contemplated that the tapered end may be ofdifferent angles than depicted in FIG. 13.

Referring back to FIGS. 9 and 10 c, the exterior of the housing 404forms two external channels. To facilitate easy movement of the slider,the slider 406 of FIG. 9 is shown to move along an external channel 412and another external channel on an opposing side (see FIG. 10 c). Morespecifically, as shown in FIG. 10 c, a depending leg 406 a of the slider406 extends into the channel 412, while a second depending leg 406 bextends into the opposing external channel. To enable easier gripping bythe user, the slider 406 may form ridges or serrations on a top surfacethereof such as show in FIGS. 9 and 10 c.

It is contemplated that other sliders may be used in thesensor-dispensing instrument. For example, in FIG. 15, asensor-dispensing instrument 450 is shown that includes a pusherassembly 452, instrument housing 454, and a slider 456. The slider 456has only one depending leg 456 a that engages into a side channel. Inthis embodiment, the instrument housing 454 forms exactly one exteriorside channel for guiding the slider 456 during movement betweenpositions.

Another example is shown in FIG. 16 with a sensor-dispensing instrument500 that includes a pusher assembly 502, instrument housing 504, and aslider 506. The pusher assembly 502 of FIG. 16 includes the slider 506and a flat bar 508 in which the slider 506 is attached to the flat bar508 via extension 506 a. In this embodiment, the instrument housing 504does not form an exterior side channel for guiding the slider duringmovement between the first and second positions.

Referring back to FIG. 10 c, the flat bar 408 is located in an internalchannel 414 that assists in facilitating the movement of the flat bar408 from a first position (FIG. 11) and a second position (FIG. 12). Thepusher assembly 402 also includes a guiding block 416 to further ensurethat the flat bar 408 is moving in a proper plane. The guiding black 416moves along a lower surface of the internal channel 414. Similarly, theslider 506 of FIG. 16 also includes an internal channel 514 and aguiding block 516 to assist in moving and positioning the flat bar 508.

According to one process, the flat bar 408 of FIGS. 11 and 12 extendsthrough an opening 420 and then extends through the moveable seal 18 band subsequently contacts one of the plurality of test sensors 14 (seeFIG. 12). The opening 420 properly aligns the flat bar 408 with respectto the moveable seals 18 a,b, as well as one of the plurality of testsensors 14. As the slider 406 is continued to be moved in the directionof arrow B in FIG. 10 a, the flat bar 408 contacts and pushes one of theplurality of test sensors 14 through seal 18 a. As the slider 406 ismoved to the second position (see FIG. 10 b), the flat bar 408 of FIG.12 continues to push one of the plurality of test sensors 14 until thesensor has at least partially passed through the dispensing outlet 410.

If electrochemical sensors are used in the sensor-dispensing instrument400, then one of the test sensors 14 will be positioned appropriately bythe flat bar 408 to the electrical contact 434. In other words, the flatbar 408 will push the test sensor to a position that will properly alignthe test sensor 14 with the electrical contact 434. It is contemplatedthat the electrical contact 434 includes a plurality of contacts that ispositioned to correspond to the test sensor. The front end of the sensor14 then receives, for example, a drop of blood to be tested, whereby theblood is analyzed by the electrical contact 434. The results of theanalysis are then displayed on a liquid crystal display 440 of FIG. 9(which will be discussed in more detail below) of the sensor-dispensinginstrument 400. It is contemplated that other type of sensors may beused such as optical sensors.

The testing end of the sensor is adapted to be placed into contact withthe fluid sample (e.g., a whole blood sample) to be tested. The wholeblood sample may be generated by a lancing device such as a lancet. Thewhole blood sample may be obtained by a lancet that may be separate fromthe sensor-dispensing instrument or may be integrated within thesensor-dispensing instrument. The lancing device may obtain blood by,e.g., pricking a person's finger.

According to one process, the whole blood sample may be prepared bytesting by (a) advancing one of the test sensors in position to receivea whole blood sample; (b) generating a whole blood sample; and (c)bringing the test sensor and the whole blood sample into contact whereinthe blood is generally drawn into the sensor by capillary action.

The sensors are typically provided with a capillary channel that extendsfrom the front or testing end of the sensors to biosensing or reagentmaterial disposed in the sensor. When the testing end of the sensor isplaced into fluid (e.g., blood that is accumulated on a person's fingerafter the finger has been pricked), a portion of the fluid is drawn intothe capillary channel by capillary action. The fluid then chemicallyreacts with the reagent material in the sensor so that an electricalsignal indicative of the blood glucose level in the blood being testedis supplied and subsequently transmitted to an electrical assembly.

After the testing has been completed, the test sensor may be removed byseveral methods from the sensor-dispensing instrument 400. In oneembodiment, the sensor-dispensing instrument may include a ejectmechanism 438 that ejects the used test sensor from thesensor-dispensing instrument. In such an embodiment, the test sensors isreleased forcefully. In another embodiment, the test sensors may beejected by releasing a grip of the test sensors, resulting in the testsensor being discarded by gravity from the sensor-dispensing instrument.In a further embodiment, the test sensor may also be removed manuallyfrom the sensor-dispensing instrument.

As shown in FIG. 12, the flat bar 408 may extend through seal 18 a whenbeing moved to the second position. It is contemplated that the flat bar408 may only extend through only seal 18 b when contacting and pushingone of the test sensors. In some embodiments, such as FIG. 6, a flat barmay not extend through any of the moveable seals during the process ofpushing the test sensors to and at least partially through thedispensing outlet.

Referring back to FIG. 10 b, the slider 406 is moved in the direction ofarrow C from its second position to the first position of FIG. 10 a.Simultaneously, the flat bar 408 is also moved from it second positionto the first position, resulting in the flat bar 408 passing throughseals 18 a,b. While the slider 406 and the flat bar 408 are in the firstposition, the cartridge 10 is substantially moisture-proof andair-tight. It is contemplated that the sensor-dispensing instrument mayactivate the slider mechanism automatically such as in response topressing a button.

FIG. 14 depicts various positions of the slider 406 that may used invarious embodiments of a sensor-dispensing instrument. A first position406 a is depicted that is the same position as previously describedabove with respect to FIGS. 9 and 10 a. A second position 406 b isdepicted that is the same position as previously described above withrespect to FIG. 10 b. The slider may also be moved to other positionsfor various functions. For example, in FIG. 14, a slider may be able toproceed to a third position 406 c. For improved clarity, only a portionof slider in the third position 406 c is shown even though the slidersin each position of FIG. 14 are the same size. The third position 406 cof the slider may be used with cartridge 260 of FIG. 6 when thecartridge 260 is being loaded into the sensor-dispensing machine. Thus,when the slider is returned to the first position 406 a, the flat bar408 enters the opening end 270 b of the disposable cartridge 260 to forma fitted seal. A slider may have a fourth position 406 d that is used toeject a test sensor by force. For improved clarity, only a portion ofslider in the fourth position 406 d is shown even though the sliders ineach position are the same size. It is contemplated that thesensor-dispensing instrument may allow the slider to move to more orless than the positions depicted in FIG. 14.

In certain embodiments of the invention, a spring (not shown) may beattached to the slider 406 that would permit the slider to return to thefirst position 406 a from any other position.

The housing 404 and the slider 406 is typically made of a polymericmaterials. Non-limiting examples of polymeric materials includepolycarbonate, ABS, nylon, polypropylene, or combinations thereof.Additives may be added to the polymeric material that forms the slider.It is contemplated that the slider may be made of other materials suchas metallic materials.

The flat bar 408 also may be made of metal or polymeric material. Somenon-limited metallic materials include stainless steel and bronze withappropriate plating. Non-limiting examples of polymeric materialsinclude polycarbonate, ABS, nylon, polypropylene, or combinationsthereof. Additives may be added to the polymeric material that forms theflat bar.

The sensor-dispensing instrument 400 also includes a bar code reader 444(see FIGS. 11 and 12) that reads a bar code label on a disposablecartridge. The bar code reader 444 can determine information such as thelot number and calibration numbers. The sensor-dispensing instrument 400typically includes a microprocessor or the like for processing and/orstoring data generated during the blood glucose test procedure. Thisdata may be displayed on the liquid crystal display 440 of FIG. 9 in thesensor-dispensing instrument 400.

The liquid crystal display 440 displays information from the testingprocedure and/or in response to signals input by a button set 442 on thesensor-dispensing instrument 400. For example, the button set may bedepressed to recall and view the results of prior testing procedures onthe liquid crystal display 440.

The button set 442 comprises several individual buttons 442 a,b,c thatare depressed to operate the electronics of the sensor-dispensinginstrument 400. The buttons may also be depressed to recall and havedisplayed on the liquid crystal display 440 the results of prior testingprocedures. The buttons may also be used to set and display date andtime information, and to activate reminder alarms that remind the userto conduct, for example, a blood glucose test according to apredetermined schedule. The buttons may also be used to activate certaincalibration procedures for the sensor-dispensing instrument 400.

Some of the information that may be displayed when the sensor-dispensinginstrument include the following: a battery indication, a numericaldisplay, an indication of the number of sensors remaining, an indicationto load a cartridge into the sensor-dispensing instrument, apply bloodindication, a temperature indication, or various combinations thereof.

The sensor-dispensing instrument 400 may also contain an opening for abattery-tray assembly. The battery-tray assembly includes a battery-trayin which a battery is disposed. The battery-tray assembly is insertedinto the opening in a side of the sensor-dispensing instrument 400. Whenso inserted, the battery provides power for the electronics within theinstrument 400, including the circuitry on the circuit board assembly(not shown) and the liquid crystal display 440.

Alternative Embodiment A

A disposable cartridge adapted to be used with a sensor-dispensinginstrument, the disposable cartridge comprising:

a housing forming at least one opening therethrough;

a plurality of test sensors being stacked in the housing, the pluralityof test sensors being adapted to assist in testing at least one analyte;

a mechanical mechanism adapted to urge the plurality of test sensors ina first direction, one of the plurality of test sensors being positionedfor ejection from the cartridge; and

a plurality of moveable seals being adapted to be in a closed positionthat seals the at least one opening so as to provide a substantiallymoisture-proof and a substantially air-tight cartridge, and one of theplurality of moveable seals being adapted to be in an open position thatallows one of the plurality of test sensors to be moved therethrough.

Alternative Embodiment B

The cartridge according to embodiment A wherein the mechanical mechanismis a spring.

Alternative Embodiment C

The cartridge according to embodiment A wherein the housing formsexactly one opening.

Alternative Embodiment D

The cartridge according to embodiment A wherein each of the plurality ofmoveable seals is a duckbill seal.

Alternative Embodiment E

The cartridge according to embodiment A wherein each of the plurality ofmoveable seals is a spring seal.

Alternative Embodiment F

The cartridge according to embodiment A wherein each of the plurality ofmoveable seals is a hollow tube.

Alternative Embodiment G

The cartridge according to embodiment A wherein each of the plurality ofmoveable seals is a pivotable seal.

Alternative Embodiment H

The cartridge according to embodiment A wherein the analyte is glucose.

Alternative Embodiment I

The cartridge according to embodiment A further including desiccant.

Alternative Embodiment J

The cartridge according to embodiment A wherein the plurality of sensorsis electrochemical sensors.

Alternative Embodiment K

The cartridge according to embodiment A wherein the plurality of sensorsis optical sensors.

Alternative Embodiment L

The cartridge according to embodiment A wherein the cartridge comprisesa main-housing portion and a lid-housing portion.

Alternative Embodiment M

The cartridge according to embodiment L wherein at least one of themain-housing portion and the lid-housing portion includes at least oneenergy detectors.

Alternative Embodiment N

The cartridge according to embodiment A wherein the cartridge comprisesa notch.

Alternative Embodiment O

A disposable cartridge adapted to be used with a sensor-dispensinginstrument, the disposable cartridge comprising:

a housing forming at least one opening therethrough;

a plurality of test sensors being stacked in the housing, the pluralityof test sensors being adapted to assist in testing at least one analyte;

a mechanical mechanism adapted to urge the plurality of test sensors ina first direction, one of the plurality of test sensors being positionedfor ejection from the cartridge; and

a moveable seal being adapted to be in a closed position that seals theat least one opening so as to provide a substantially moisture-proof anda substantially air-tight cartridge, the moveable seal being adapted tobe in an open position that allows one of the plurality of test sensorsto be moved therethrough.

Alternative Embodiment P

A sensor-dispensing instrument comprising:

a disposable cartridge comprising a housing forming at least one openingtherethrough, a plurality of test sensors being stacked in the housing,the plurality of test sensors adapted to assist in testing at least oneanalyte, a mechanical mechanism adapted to urge the plurality of testsensors in a first direction, one of the plurality of test sensors beingpositioned for ejection from the cartridge; at least one moveable sealbeing adapted to be in a closed position that seals the at least oneopening so as to provide a substantially moisture-proof and asubstantially air-tight cartridge, the at least one moveable seal beingadapted to be in an open position that allows one of the plurality oftest sensors to be moved therethrough;

a housing forming a dispensing outlet and being adapted to receive thedisposable cartridge; and

a pusher assembly that includes a slider and a thin flat bar coupled tothe pusher assembly, the flat bar being adapted to slide from a firstposition to a second position on movement of the pusher assembly,

wherein during the movement of the flat bar from the first position tothe second position, the flat bar contacts one of the plurality of testsensors and pushes it at least partially through at least one of themoveable seals.

Alternative Embodiment Q

The instrument according to embodiment of P wherein thesensor-dispensing instrument is a blood glucose meter.

Alternative Embodiment R

A disposable cartridge adapted to be used with a sensor-dispensinginstrument, the disposable cartridge comprising:

a housing forming at least one opening therethrough;

a plurality of test sensors being stacked in the housing, the pluralityof test sensors being adapted to assist in testing at least one analyte;

a mechanical mechanism adapted to urge the plurality of test sensors ina first direction such that one of the plurality of test sensors ispositioned for ejection from the cartridge, the mechanical mechanismincluding a torsion spring; and

a plurality of moveable seals being adapted to be in a closed positionthat seals the at least one opening so as to provide a substantiallymoisture-proof and a substantially air-tight cartridge, and one of theplurality of moveable seals being adapted to be in an open position thatallows one of the plurality of test sensors to be moved therethrough.

Alternative Embodiment S

The cartridge according to embodiment R wherein the mechanical mechanismfurther includes a movable pressure plate.

Alternative Embodiment T

The cartridge according to embodiment R wherein the housing formsexactly one opening.

Alternative Embodiment U

The cartridge according to embodiment R wherein each of the plurality ofmoveable seals is a duckbill seal.

Alternative Embodiment V

The cartridge according to embodiment R wherein the analyte is glucose.

Alternative Embodiment W

The cartridge according to embodiment R further including desiccant.

Alternative Embodiment X

The cartridge according to embodiment R wherein the plurality of sensorsis electrochemical sensors.

Alternative Embodiment Y

The cartridge according to embodiment R wherein the plurality of sensorsis optical sensors.

Alternative Embodiment Z

A disposable cartridge adapted to be used with a sensor-dispensinginstrument, the disposable cartridge comprising:

a housing forming at least one opening therethrough;

a plurality of test sensors being stacked in the housing, the pluralityof test sensors being adapted to assist in testing at least one analyte;

a mechanical mechanism adapted to urge the plurality of test sensors ina first direction such that one of the plurality of test sensors ispositioned for ejection from the cartridge, the mechanical mechanismincluding a torsion spring; and

a moveable seal being adapted to be in a closed position that seals theat least one opening so as to provide a substantially moisture-proof anda substantially air-tight cartridge, the moveable seal being adapted tobe in an open position that allows one of the plurality of test sensorsto be moved therethrough.

Alternative Embodiment AA

A sensor-dispensing instrument comprising:

a disposable cartridge comprising a housing forming at least one openingtherethrough, a plurality of test sensors being stacked in the housing,the plurality of test sensors adapted to assist in testing at least oneanalyte, a mechanical mechanism adapted to urge the plurality of testsensors in a first direction such that one of the plurality of testsensors is positioned for ejection from the cartridge, the mechanicalmechanism including a torsion spring; at least one moveable seal beingadapted to be in a closed position that seals the at least one openingso as to provide a substantially moisture-proof and a substantiallyair-tight cartridge, the at least one moveable seal being adapted to bein an open position that allows one of the plurality of test sensors tobe moved therethrough;

a housing forming a dispensing outlet and being adapted to receive thedisposable cartridge; and

a pusher assembly that includes a slider and a thin flat bar coupled tothe pusher assembly, the flat bar being adapted to slide from a firstposition to a second position on movement of the pusher assembly,

wherein during the movement of the flat bar from the first position tothe second position, the flat bar contacts one of the plurality of testsensors and pushes it at least partially through at least one of themoveable seals.

Alternative Embodiment BB

The instrument according to embodiment of AA wherein thesensor-dispensing instrument is a blood glucose meter.

While the invention has been described with reference to details of theillustrated embodiment, these details are not intended to limit thescope of the invention as defined in the appended claims. For example,the sensor-dispensing instrument 400 can be used for testing fluidsother than blood glucose. In fact, the sensor-dispensing instrument 400can be used in connection with the analysis of any type of chemistryfluid that can be analyzed by means of a reagent material.

1. A disposable cartridge adapted to be used with a sensor-dispensinginstrument, the disposable cartridge comprising: a housing forming atleast one opening therethrough; a plurality of test sensors beingstacked in the housing, the plurality of test sensors being adapted toassist in testing at least one analyte; a mechanical mechanism adaptedto urge the plurality of test sensors in a first direction, one of theplurality of test sensors being positioned for ejection from thecartridge; and a plurality of moveable seals being adapted to be in aclosed position that seals the at least one opening so as to provide asubstantially moisture-proof and a substantially air-tight cartridge,and one of the plurality of moveable seals being adapted to be in anopen position that allows one of the plurality of test sensors to bemoved therethrough.
 2. The cartridge according to claim 1 wherein themechanical mechanism is a spring.
 3. The cartridge according to claim 1wherein the housing forms exactly one opening.
 4. The cartridgeaccording to claim 1 wherein each of the plurality of moveable seals isa duckbill seal.
 5. The cartridge according to claim 1 wherein each ofthe plurality of moveable seals is a spring seal.
 6. The cartridgeaccording to claim 1 wherein each of the plurality of moveable seals isa hollow tube.
 7. The cartridge according to claim 1 wherein each of theplurality of moveable seals is a pivotable seal.
 8. The cartridgeaccording to claim 1 wherein the analyte is glucose.
 9. The cartridgeaccording to claim 1 further including desiccant.
 10. The cartridgeaccording to claim 1 wherein the plurality of sensors is electrochemicalsensors.
 11. The cartridge according to claim 1 wherein the plurality ofsensors is optical sensors.
 12. The cartridge according to claim 1wherein the cartridge comprises a main-housing portion and a lid-housingportion.
 13. The cartridge according to claim 12 wherein at least one ofthe main-housing portion and the lid-housing portion includes at leastone energy detectors.
 14. The cartridge according to claim 1 wherein thecartridge comprises a notch.
 15. A disposable cartridge adapted to beused with a sensor-dispensing instrument, the disposable cartridgecomprising: a housing forming at least one opening therethrough; aplurality of test sensors being stacked in the housing, the plurality oftest sensors being adapted to assist in testing at least one analyte; amechanical mechanism adapted to urge the plurality of test sensors in afirst direction, one of the plurality of test sensors being positionedfor ejection from the cartridge; and a moveable seal being adapted to bein a closed position that seals the at least one opening so as toprovide a substantially moisture-proof and a substantially air-tightcartridge, the moveable seal being adapted to be in an open positionthat allows one of the plurality of test sensors to be movedtherethrough.
 16. A sensor-dispensing instrument comprising: adisposable cartridge comprising a housing forming at least one openingtherethrough, a plurality of test sensors being stacked in the housing,the plurality of test sensors adapted to assist in testing at least oneanalyte, a mechanical mechanism adapted to urge the plurality of testsensors in a first direction, one of the plurality of test sensors beingpositioned for ejection from the cartridge; at least one moveable sealbeing adapted to be in a closed position that seals the at least oneopening so as to provide a substantially moisture-proof and asubstantially air-tight cartridge, the at least one moveable seal beingadapted to be in an open position that allows one of the plurality oftest sensors to be moved therethrough; a housing forming a dispensingoutlet and being adapted to receive the disposable cartridge; and apusher assembly that includes a slider and a thin flat bar coupled tothe pusher assembly, the flat bar being adapted to slide from a firstposition to a second position on movement of the pusher assembly,wherein during the movement of the flat bar from the first position tothe second position, the flat bar contacts one of the plurality of testsensors and pushes it at least partially through at least one of themoveable seals.
 17. The instrument according to claim 16 wherein thesensor-dispensing instrument is a blood glucose meter.
 18. A disposablecartridge adapted to be used with a sensor-dispensing instrument, thedisposable cartridge comprising: a housing forming at least one openingtherethrough; a plurality of test sensors being stacked in the housing,the plurality of test sensors being adapted to assist in testing atleast one analyte; a mechanical mechanism adapted to urge the pluralityof test sensors in a first direction such that one of the plurality oftest sensors is positioned for ejection from the cartridge, themechanical mechanism including a torsion spring; and a plurality ofmoveable seals being adapted to be in a closed position that seals theat least one opening so as to provide a substantially moisture-proof anda substantially air-tight cartridge, and one of the plurality ofmoveable seals being adapted to be in an open position that allows oneof the plurality of test sensors to be moved therethrough.
 19. Thecartridge according to claim 18 wherein the mechanical mechanism furtherincludes a movable pressure plate.
 20. The cartridge according to claim18 wherein the housing forms exactly one opening.
 21. The cartridgeaccording to claim 18 wherein each of the plurality of moveable seals isa duckbill seal.
 22. The cartridge according to claim 18 wherein theanalyte is glucose.
 23. The cartridge according to claim 18 furtherincluding desiccant.
 24. The cartridge according to claim 18 wherein theplurality of sensors is electrochemical sensors.
 25. The cartridgeaccording to claim 18 wherein the plurality of sensors is opticalsensors.
 26. A disposable cartridge adapted to be used with asensor-dispensing instrument, the disposable cartridge comprising: ahousing forming at least one opening therethrough; a plurality of testsensors being stacked in the housing, the plurality of test sensorsbeing adapted to assist in testing at least one analyte; a mechanicalmechanism adapted to urge the plurality of test sensors in a firstdirection such that one of the plurality of test sensors is positionedfor ejection from the cartridge, the mechanical mechanism including atorsion spring; and a moveable seal being adapted to be in a closedposition that seals the at least one opening so as to provide asubstantially moisture-proof and a substantially air-tight cartridge,the moveable seal being adapted to be in an open position that allowsone of the plurality of test sensors to be moved therethrough.
 27. Asensor-dispensing instrument comprising: a disposable cartridgecomprising a housing forming at least one opening therethrough, aplurality of test sensors being stacked in the housing, the plurality oftest sensors adapted to assist in testing at least one analyte, amechanical mechanism adapted to urge the plurality of test sensors in afirst direction such that one of the plurality of test sensors ispositioned for ejection from the cartridge, the mechanical mechanismincluding a torsion spring; at least one moveable seal being adapted tobe in a closed position that seals the at least one opening so as toprovide a substantially moisture-proof and a substantially air-tightcartridge, the at least one moveable seal being adapted to be in an openposition that allows one of the plurality of test sensors to be movedtherethrough; a housing forming a dispensing outlet and being adapted toreceive the disposable cartridge; and a pusher assembly that includes aslider and a thin flat bar coupled to the pusher assembly, the flat barbeing adapted to slide from a first position to a second position onmovement of the pusher assembly, wherein during the movement of the flatbar from the first position to the second position, the flat barcontacts one of the plurality of test sensors and pushes it at leastpartially through at least one of the moveable seals.
 28. The instrumentaccording to claim 27 wherein the sensor-dispensing instrument is ablood glucose meter.